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The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be defined if it is at one of the three dose levels under study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combretastatin A4 Phosphate (CA4P) | Drug | |||
| Bevacizumab (Avastin) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of the combination therapy assessed by analysis of adverse events | ||
| safety and tolerability of the combination therapy assessed by analysis of laboratory tests | ||
| safety and tolerability of the combination therapy assessed by analysis of other assessments within the protocol |
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Inclusion Criteria:
Histopathologically or cytologically confirmed malignant solid tumors that have failed standard therapy or for which no life prolonging treatment exists
Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
At least 4 weeks since any prior immunotherapy, chemotherapy or radiation therapy prior to first dose of study drug (six weeks for therapy known to be associated with delayed toxicity such as nitrosoureas or mitomycin-C)
Age > or = to 18 years old
Adequate bone marrow function:
Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
Adequate hepatic function:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy of > or = to 12 weeks
Written, signed, dated, and witnessed (if applicable as per International Conference on Harmonization [ICH] guidelines) Independent Ethics Committee (IEC) approved informed consent form before any study specific screening procedures are performed
Fertile subjects must abstain from sexual intercourse or use effective birth control.
All women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of first dose.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Nathan, MD | Mount Vernon Hospital | Principal Investigator |
| Hillori Connors, MS | Mateon Therapeutics | Study Director |
| Peter Harris, MD | Mateon Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Vernon Hospital | Northwood | Middlesex | HA6 2RN | United Kingdom | ||
| Royal Marsden Hospital |
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| Sutton |
| Surrey |
| SM2 5PT |
| United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C058728 | fosbretabulin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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